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FDA Publishes Strategy for Advancing Regulatory Science
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Angie Drakulich
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FDA released a strategic plan to advance regulatory science on Aug. 17, 2011, in an effort to "keep pace with and utilize...new scientific advances," and to promote public health. The plan is based on the agency's five-year strategic goals and its October 2010 report on advancing regulatory science.
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Ben Venue Laboratories Exits Contract Manufacturing Business
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Erik Greb
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Last week, Ben Venue Laboratories decided to exit the contract-manufacturing business during the next several years, thus ending more than 70 years of service in this field. To ensure the supply of medically necessary products, the company will work with its customers to develop and execute long-term transition plans.
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Catalent to Acquire Aptuit's Clinical-Trial Supply Business
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Patricia Van Arnum
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To further enhance its position in clinical-trial materials supply, Catalent Pharma Solutions has agreed to acquire the clinical-trial supplies business of Aptuit for $410 million on a cash and debt-fee basis.
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Drug Shortages Loom Large
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Amy Ritter
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In 2010, FDA recorded nearly 180 drug shortages, triple the number recorded in 2005. Most of the drugs that experienced shortages were sterile injectables, including cancer medications and anesthetics.
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GSK Takes $2.06-Million Stake in New Spin Out Autifony Therapeutics
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Stephanie Sutton
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GlaxoSmithKline has taken a stake worth £1.25 million ($2.06 million) in its biotech spin out company, Autifony Therapeutics, which aims to develop new treatments for hearing disorders.
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$1.32 Billion Pledged for Translational Research in UK
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Rich Whitworth
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The UK government announced that a record £800 million ($1.32 billion) in funding would be set aside for translational research to boost the development of medicines, treatments, and care for patients, particularly in the fields of cancer, diabetes, and heart disease.
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Week of August 22, 2011: Eisai Establishes New Pharma Sales Subsidiary in Mexico; Cangene Names John A. Sedor as President and CEO; and More
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Eisai Establishes New Pharma Sales Subsidiary in Mexico; Cangene Names John A. Sedor as President and CEO; and More.
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